The Next Generation CRO

Empowering biotech companies with scientific insights and cutting-edge technologies, ensuring long-term success of their clinical development plans— from early phase to pivotal trials.

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The CRO for Biotechs

We specialise in biotech development, navigating complexity with clarity, speed and scientific rigour.

Pivotal understands the unique challenges and aspirations of biotech companies. Our deep-rooted focus in clinical research sector makes us agile and flexible, enabling us to tailor our approach to your specific needs — delivering expert guidance and operational excellence from early development through pivotal trials.

Why Biotechs choose us?

Pivotal is a full-service CRO that delivers on time and within budget.

100%

Flexibility

We pivot together with our client’s strategy and operational needs ensuring long-term success.

>540

Trials

We are a trusted partner with deep, long-established relationships with PIs and sites that accelerate trial delivery.

MDs on staff

Our deeply scientific medical team is the cornerstone of Pivotal, supporting our clients in both their scientific and operational strategies.

What our clients say

Feedback from our clients worldwide.

Pivotal continues to be my CRO of choice. They complement our existing team by providing functional area expertise that we do not currently possess. Their personnel are highly engaged, and proficient in what they do. Pivotal’s leadership team is experienced and, more importantly, incredibly engaged throughout the entire study. These are some of the reasons Pivotal continues to be a trusted partner for us.

Randy Brown
Former COO
Lucid Diagnostics

We have worked with Pivotal for more than 4 years now. During this time, Pivotal´s team has been able to accommodate all our specific needs, always providing the right services. They are easily accessible and very dedicated to making things work. Undoubtedly, Pivotal is a key partner for us in the clinical development of our asset.

Marisol Quintero, PhD
CEO
Highlight Therapeutics

I have worked with Pivotal on two studies and have been particularly impressed with the care they give studies, their personal attention to the needs of sponsors, and their dedication to getting things right. Pivotal is a closely knit group. There is no bureaucracy, simply the dedication to serving the needs of their biotech clients. They are the closest thing I can find to having my company personnel on the ground in Spain and Europe.

M. Scott Harris, MD
CMO
Altimmune, Inc.

I have been working with Pivotal since 2014 on 6 projects in GU tumors and what I have encountered is a dedicated team to clinical research, very much attentive to the detailed needs of independent investigators, responsiveness and quality-minded throughout. Pivotal is my favorite CROs to work with and have no hesitation to recommend for any new trials in Oncology and beyond.

Joaquim Bellmunt Molins
MD, PhD Senior Researcher PSMAR/IMIM Hospital del Mar, Barcelona, Spain
Associate Professor of Medicine Harvard Medical School

“Pivotal was an invaluable partner in our Non-Muscle Invasive Bladder Cancer (NMIBC) gene therapy study. Their team continued to demonstrate exceptional efficiency during feasibility and start-up as well as trial´s implementation. I was particularly impressed by their strategic and tactical thinking and proactive handling of blocks. I would highly recommend Pivotal to any biotech seeking a reliable and capable CRO partner.”

Richard Bryce, MD, MMFP
Former CMO
enGene

The team at Pivotal operates as a seamless extension of our internal team, building trust with our European clinical trial sites and our confidence in our ability to execute high-quality clinical trials. The Pivotal management team acts as a true partner, equally focused on our objectives to develop innovative therapeutic treatments to patients with serious unmet medical needs.

Leslie Barnes
Group VP, Strategic R&D Operations
BioMarin Pharmaceutical Inc

Randy Brown
Former COO
Lucid Diagnostics

Marisol Quintero, PhD
CEO
Highlight Therapeutics

M. Scott Harris, MD
CMO
Altimmune, Inc.

Joaquim Bellmunt Molins
MD, PhD Senior Researcher PSMAR/IMIM Hospital del Mar, Barcelona, Spain
Associate Professor of Medicine Harvard Medical School

Richard Bryce, MD, MMFP
Former CMO
enGene

Leslie Barnes
Group VP, Strategic R&D Operations
BioMarin Pharmaceutical Inc

Randy Brown
Former COO
Lucid Diagnostics

Marisol Quintero, PhD
CEO
Highlight Therapeutics

Our Solutions for Biotechs

We offer end-to-end clinical development solutions tailored to your needs. Whether you’re preparing for first-in-human or managing a global Phase 3 trial, our agile team delivers expertise, insight, and hands-on support at every stage.

Study Start-Up
& Regulatory

Project
Management

Patient Journey,
Recruitment & Retention

Clinical Trial
Monitoring

Medical Services
& Monitoring

Study Start-Up
& Regulatory

Project
Management

Patient Journey,
Recruitment & Retention

Clinical Trial
Monitoring

Medical Services
& Monitoring

Pharmacovigilance

Data
Science

Biostatistics

Quality
Assurance & Compliance

Quality
Assurance & Compliance

Decentralized
Trials

Translate

novel science

into new

clinical treatments

THERAPEUTIC AREAS

Scientifically led clinical trials

Our team of MDs bring unparalleled scientific expertise to every project. With a deep understanding of complex therapeutic areas, we deliver data-driven solutions that drive your drug development efforts forward.